Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05135052




Registration number
NCT05135052
Ethics application status
Date submitted
8/10/2021
Date registered
26/11/2021
Date last updated
8/04/2022

Titles & IDs
Public title
Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer.
Scientific title
Efficacy of Personalised Irradiation With Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer: A Phase IV, Multi-Centre, International, Open-Label, Single Arm Study.
Secondary ID [1] 0 0
OB-RHSCT-101
Universal Trial Number (UTN)
Trial acronym
EPIC-Skin
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-melanoma Skin Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma
Cancer 0 0 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Rhenium-SCT

Experimental: Treatment arm - Treatment with Rhenium-SCT, Single treatment.


Treatment: Devices: Rhenium-SCT
Rhenium-SCT irradiation device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Complete Response (CR) with Modified Visual RECIST tool
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
SKINDEX-16 QoL Questionnaire
Timepoint [1] 0 0
6 months and 12 months
Secondary outcome [2] 0 0
Comfort of Treatment short questionnaire
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
cosmetic outcomes by Visual Analogue Scale
Timepoint [3] 0 0
12 months and 24 months

Eligibility
Key inclusion criteria
1. Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node
negative disease

2. Confirmed Histology, and with depth of lesion noted

3. Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3
lesions are not excluded from the study, however 3 target lesions are determined for
study evaluation only.)

4. Subjects able and willing to comply with the requirements of the study

5. Age >=18 years

6. Informed Consent signed by the subject consenting to undergo the study

7. Lesions up to 8cm2

8. Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate
clinically by treating clinician

9. Subjects who are not deemed suitable for surgery, for example due to tumour location,
performance status or other comorbidities as deemed relevant by the treating clinician

10. Patients who may have declined Surgery and/or fractionated Radiation Therapy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to personally provide written informed consent or to understand and
collaborate throughout the study

2. Inability or unwillingness to comply with study requirements

3. Prior treatment with surgery or radiation therapy for their target lesion(s)

4. Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment

5. Lupus and Scleroderma

6. Basal cell naevus syndrome, xeroderma, vitiligo and albinism

7. Prior laser at the tumour site

8. Malignant melanoma systemic therapy ongoing

9. Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry

10. A tumour affecting nerves or bony structures

11. Clinical concern of metastatic disease

12. Pregnancy and/or Lactation

13. Pathological exclusions: Perineural Invasion, Lymphovascular invasion

14. Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower),
Vermillion lip

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/05/2024
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Genesis Care Health Hub at RNS - Sydney
Recruitment hospital [2] 0 0
John Flynn Hospital - Tugun
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
4224 - Tugun

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
OncoBeta Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment
of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm
study.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05135052
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerhard Dr Dahlhoff, MD
Address 0 0
Oncobeta GmbH
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gerhard Dr Dahlhoff, MD
Address 0 0
Country 0 0
Phone 0 0
08136808989
Fax 0 0
Email 0 0
gerhard.dahlhoff@oncobeta.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05135052